title: The ethics of paediatric trials: questions of procedure and of substance.
abstract: One of the more frequently debated questions about the ethics of research with children is that of informed consent. This raises a twofold problem: the legally valid consent given by the person or persons exercising parental authority, and the consent of the minor when he or she has adequate decision-making capacity. Another ethically important issue is the weighing of risks and benefits. Any assessment of the benefits will embrace the controversial problem of balancing the direct benefits to the individual and the social benefits to other children in similar medical circumstances deriving from increased knowledge. The highly significant questions of risk and of the advancement of knowledge are often - perhaps too emphatically - taken together with that of consent, as though the existence of legally valid consent and, where possible, the assent of the minor were sufficient to justify exposing a child to serious or probable risks.
authors.affiliation: Istituto Superiore di Sanità, Italian National Institute of Health, Rome, Italy. carlo.petrini@iss.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Petrini
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D033282:Parental Consent / Q000941:ethics*